MAUDE Adverse Event Report: ZIMMER BIOMET SPINE, INC. OPTIO-C,PEEK IB,14X16X6MM; OPTIO-C ANTERIOR CERVICAL SYSTEM

Catalog Number	07.01859.006
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.Reference report 3012447612-2024-00320.
Event or Problem Description
It was reported that when and optio-c plate and peek implant were placed onto the assembly block during surgery on the back table, the connection between the two was very loose.They were not implanted, instead, another set of implants were opened to complete the procedure.There was no patient impact; however, there was a five minute delay for opening and placement of the new implants.This is report two of two for this event.
Additional Manufacturer Narrative
H3: "device evaluation anticipated, but not yet begun" is erroneous and no longer applies.The device was evaluated.Corrections in h3.Additional information in h6: investigation type, findings, and conclusions.Device evaluation: the returned device matches the information in the complaint file and was examined.Visual inspection revealed the plate is loosely connected to the peek cage.One of the retention tabs is splayed and the plate was able to be disassembled from the peek.No damage was identified on the peek.Root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to plate tab being splayed, making the connection loose.Dhr review: the dhr was reviewed.There are no indications of manufacturing issues which would have contributed to this event and the device was likely conforming when it left highridge medical¿s control.Device usage: this device is used for treatment.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.
Event or Problem Description
It was reported that when and optio-c plate and peek implant were placed onto the assembly block during surgery on the back table, the connection between the two was very loose.They were not implanted, instead, another set of implants were opened to complete the procedure.There was no patient impact; however, there was a five minute delay for opening and placement of the new implants.This is report two of two for this event.

• Brand Name: OPTIO-C,PEEK IB,14X16X6MM
• Common Device Name: OPTIO-C ANTERIOR CERVICAL SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE, INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer (Section G): ZIMMER BIOMET SPINE, INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer Contact: teresa george ; 10225 westmoor dr.; westminster, CO 80021 ; 3035018506
• MDR Report Key: 20727933
• Report Number: 3012447612-2024-00321
• Device Sequence Number: 18235295
• Product Code: OVE
• UDI-Device Identifier: 00889024329454
• UDI-Public: (01)00889024329454(17)290523(10)10301
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K132894
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 07.01859.006
• Device Lot Number: 10301
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic